Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 418d480c-4131-4262-bb56-d5b10bbf7dcb
Route
TOPICAL
Published
Effective Date 2023-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (15 mg)
Inactive Ingredients
Water Alcohol Propanediol Glycolic Acid Niacinamide Dimethyl Isosorbide Pentylene Glycol Sodium Hydroxide Ppg-26-buteth-26 Hydroxyethylpiperazine Ethane Sulfonic Acid Citric Acid Monohydrate Peg-30 Glyceryl Cocoate Polyoxyl 40 Hydrogenated Castor Oil Peg-60 Hydrogenated Castor Oil Capryloyl Salicylic Acid Biosaccharide Gum-1 Maltodextrin Fytic Acid Polyquaternium-10 (10000 Mpa.s At 2%)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-01

Description

Salicylic acid 1.5%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic acid 1.5%

Uses
  • clears acne blemishes
  • penetrates pores to control acne blemishes
  • helps prevent new acne blemishes from forming
Section 51945-4

Warnings

For external use only

Directions
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • children under 12 years of age: ask a doctor
Active Ingredient

Salicylic acid 1.5%

Inactive Ingredients

water, alcohol denat., propanediol, glycolic acid, niacinamide, dimethyl isosorbide, pentylene glycol, sodium hydroxide, capitolize-26-buteth-26, PPG-26-buteth-26, hydroxyethylpiperazine ethane sulfonic acid, citric acid, PEG-30 glyceryl cocoate, PEG-40 hydrogenated castor oil, PEG-60 hydrogenated castor oil, capryloyl salicylic acid, biosaccharide gum-1, maltodextrin, phytic acid, polyquaternium-10, fragrance

Questions Or Comments?

1-888-LRP LABO

1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • clears acne blemishes
  • penetrates pores to control acne blemishes
  • helps prevent new acne blemishes from forming
Section 51945-4 (51945-4)

Purpose

Acne treatment

Warnings

For external use only

Directions
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • children under 12 years of age: ask a doctor
Active Ingredient (Active ingredient)

Salicylic acid 1.5%

Inactive Ingredients (Inactive ingredients)

water, alcohol denat., propanediol, glycolic acid, niacinamide, dimethyl isosorbide, pentylene glycol, sodium hydroxide, capitolize-26-buteth-26, PPG-26-buteth-26, hydroxyethylpiperazine ethane sulfonic acid, citric acid, PEG-30 glyceryl cocoate, PEG-40 hydrogenated castor oil, PEG-60 hydrogenated castor oil, capryloyl salicylic acid, biosaccharide gum-1, maltodextrin, phytic acid, polyquaternium-10, fragrance

Questions Or Comments? (Questions or comments?)

1-888-LRP LABO

1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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